Device recall
Z-0468-2013: Invivo Corporation Expression MRI Patient Monitoring System. The Expression MRI…
FDA device recall · Class II · Invivo Corporation
Key facts
| Recall number (Z-number) | Z-0468-2013 |
|---|---|
| Recall event | 63643 |
| Product | Invivo Corporation Expression MRI Patient Monitoring System. The Expression MRI Patient Monitoring System is intended for use by healthcare professionals to monitor vital signs for patients undergoing MRI procedures. The Patient Monitoring System also provides signals for synchronization to the MR… |
| Product code | MWI |
| Recalling firm | Invivo Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 13, 2015 |
| 510(k) numbers | K090785 |
| FEI number | 1051786 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database